Process Engineering Lead – Sterile Injectables (CMO) -SEZ

Shantha Biologics Private Limited; Hyderabad; On-site; INR 4,500,000 - 7,000,000; Full time

Job summary

Shantha Biologics Private Limited is seeking a Process Engineering Lead for Sterile Injectables at the SEZ site in Hyderabad. The role oversees process engineering, equipment qualification, and lifecycle management, ensuring GMP compliance and safety across manufacturing operations.

The candidate will drive uptime for filling lines, AVI systems, and formulation processes, coordinating with QA/QC, procurement, and engineering teams to deliver scalable, compliant manufacturing improvements.

Qualifications

• 15-20 years in pharma industry
• Strong experience in sterile injectables (preferred)
• Exposure to CMO/CDMO environment (highly preferred)
• Process Equipment maintenance & troubleshooting
• Report and mitigate potential failures
• Inventory & Cost Management

Responsibilities

• Own equipment performance for filling lines (OEE, uptime)
• Own AVI system performance and reliability
• Lead equipment qualification and requalification activities
• Drive preventive maintenance and reliability initiatives
• Lead deviations, CAPA, and change controls
• Manage risk and continuity for critical materials
• Collaborate with manufacturing, QA/QC, and procurement, and interface with global clients

Skills

Pharma process engineering

Project execution

Technical problem-solving

Cross-functional leadership

Root-cause analysis

Vendor management

Documentation & communication

Tools

SCADA systems

SAP PM module

Advanced Excel

eQMS / EDMS exposure

Job description

Process Engineering Lead - Sterile Injectables (CMO) -SEZ

Position Title:

Process Engineering Lead - Sterile Injectables (CMO) -SEZ

Location:

Muppireddipally, Hyderabad

Experience:

15-20 Years

Reports To:

Lead-Engineering/Site technical Head

Mandate

The Process Engineering Lead is responsible for providing process engineering and technical support to manufacturing operations and engineering projects at the manufacturing site.

The role will lead process-related engineering activities associated with new equipment installation, modifications, capacity expansion, process improvements, troubleshooting, commissioning, qualification, and lifecycle management while ensuring compliance with GMP, safety, quality, and regulatory requirements.

What you will own

Equipment Ownership - Filling Lines

• Ensure reliable operation and uptime of cartridge filling lines with isolator
• Own:
  • Equipment performance (OEE, breakdowns, micro-stoppages)
  • Change parts readiness and mechanical integrity
• Lead:
  • Troubleshooting of mechanical, pneumatic, and process-related failures
• Support:
  • Installation, commissioning, qualification (IQ/OQ/PQ), and upgrades

Equipment Ownership - Visual Inspection (AVI)

• Own AVI system performance and reliability
• Manage:
  • Mechanical setups (star wheels, guides, spacers)
  • Change parts lifecycle and OEM coordination
• Ensure:
  • Stable operation with minimal downtime and optimal throughput
• Support:
  • Qualification and requalification activities
• Own engineering performance of formulation systems integrated with PCS 7
• Ensure:
  • Equipment reliability (mixing, transfer, filtration systems)
  • Automation integrity (recipes, interlocks, alarms)
• Lead:
  • Troubleshooting of issues
• Support:
  • System upgrades, modifications, and change controls

Maintenance & Reliability Engineering

• Execute:
  • Execute preventive maintenance schedules as per OEM/manual.
• Drive:
  • Breakdown reduction and reliability improvement initiatives
• Maintain:
  • Critical spares strategy and inventory optimization
• Ensure:
  • Minimal downtime and high equipment availability

Qualification & Compliance

• Support and execute:
  • Equipment qualification (IQ/OQ/PQ)
  • Requalification and periodic review
• Ensure systems remain in a validated and audit-ready state
• Align with:
  • EU GMP Annex 1
  • USFDA and global regulatory expectations

Deviation, Change Control & CAPA

• Lead engineering investigations for:
  • Equipment-related deviations and failures
• Perform:
  • Root Cause Analysis (RCA) and implement CAPA
• Support:
  • Change control execution (modifications, upgrades, software changes)

Risk & Continuity Management

• Implement supply risk management strategies (dual sourcing, safety stock, alternate vendors)
• Drive FMEA-based risk assessments across supply chain operations
• Ensure business continuity plans are in place for critical materials

Stakeholder & Client Leadership

• Collaborate with Manufacturing, QA/QC, utility-engineering, and Procurement
• Interface with global clients for supply planning and commitments
• Drive governance, reporting, and KPI tracking
• Act as single point of accountability for customers
• Lead governance forums, steering reviews, and executive updates
• Build trust through data-driven, transparent communication

You bring

• 15-20 years in pharmaceutical industry
• Strong experience in sterile injectables (preferred)
• Exposure to CMO/CDMO environment (highly preferred)
• Process Equipment maintenance & troubleshooting
• Report and mitigate potential failures
• Inventory & Cost Management

Strong understanding of cGMP, EU Annex 1, SEZ operations and regulatory expectations

Who you are

• 15-20 years in pharma engineering (sterile injectables preferred)
• Core competencies:
  • Strong process engineering fundamentals
  • Project execution and coordination
  • Technical problem-solving
  • Root-cause analysis
  • Cross-functional leadership
  • Vendor and contractor management
  • Technical documentation and communication
  • Decision-making and prioritization
  • Ability to work effectively in a fast-paced manufacturing environment
  • Strong knowledge of: Mechanical systems, pneumatics, instrumentation, and automation
  • Understanding of: EU GMP Annex 1, cGMP, and validation lifecycle
  • Tools & Systems :SCADA systems, SAP PM module (preferred),Advanced Excel for performance tracking, eQMS / EDMS exposure

Success in this role (first 12 months)

• Improved OEE and reduction in breakdowns
• Stable, validated performance of MLD, AVI, and formulation systems
• Timely execution of qualification and requalification activities

Reduced engineering-related deviations and downtime

Why this role matters

Own and enhance critical aseptic manufacturing equipment with high engineering visibility and exposure to global pharma operations